RESUMO
INTRODUCTION: Oral semaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1RA) class of antidiabetic medication. High costs and GI side effects are the major limitations of its widespread use. Some patients who were on a 14 mg dose of oral semaglutide self-prescribed an alternate-day schedule to mitigate GI side effects and to reduce the cost. METHODS: This retrospective observational cohort study evaluates the ambulatory glucose profile (AGP) data, extrapolated glycosylated hemoglobin (HbA1C), and BMI of 11 types of 2 diabetes mellitus (T2DM) while they were on an alternate-day 14 mg dose of oral semaglutide compared to their record while on a daily 7 mg dose. The AGP metrics (time-in-range (TIR), time-below-range (TBR), and time-above-range (TAR)) along with extrapolated HbA1C and BMI were analyzed. Statistical analysis was done using SPSS Statistics version 21.0. RESULTS: No statistically significant difference in the AGP metrics between the AGP profile of a daily 7 mg dose and the AGP profile of an alternate-day 14 mg dose of oral semaglutide was observed. Interestingly, a statistically significant progressive decline in BMI value was observed even on the alternate-day 14 mg dose when compared to the daily 7 mg dose. CONCLUSION: In this small cohort of patients, the metrics of short-term glycemic control and the extrapolated HbA1C values were similar for the daily 7 mg dose versus the alternate-day 14 mg dose of oral semaglutide. BMI showed progressive reduction which was statistically significant even with the alternate-day 14 mg dose of oral semaglutide.
RESUMO
Introduction Oral semaglutide, with a long half-life of seven days, is the first oral-based peptide drug and is used as an antidiabetic for the reduction of glycosylated hemoglobin (HbA1c). Oral semaglutide, like other glucagon-like peptide-1 receptor agonists (GLP1RAs), is costly and has gastrointestinal (GI) side effects, especially with a 14 mg dose. In the real world, some type 2 diabetes mellitus (T2DM) patients on 14 mg oral dose adopt an alternate-day strategy to minimize unwanted GI symptoms. In this study, we analyzed the ambulatory glucose profile (AGP) data of patients with T2DM who were on 14 mg alternate-day oral semaglutide therapy. Methods This retrospective observational study evaluated the AGP data of 10 patients on alternate-day dosing of 14 mg oral semaglutide. The AGP data over a period of 14 days on a single group of patients were analyzed without any control group or randomization and are presented as a case series. AGP monitoring, using Freestyle Libre Pro (Abbott, Illinois, United States), is a standard operating procedure of the endocrinology department for all T2DM patients who were put on oral semaglutide therapy. The AGP data of the glycemic parameters time-in-range (TIR), time-above-range (TAR), and time-below-range (TBR), were compared between the days when oral semaglutide was consumed (days-on-drug) versus the days when oral semaglutide was not consumed (days-off-drug). The statistical analysis was done with Statistical Package for Social Sciences (SPSS) version 21.0 (IBM Corp., Armonk, NY). Results We applied the Shapiro-Wilk test (sample size <50) for normality testing; the TIR values of days-on-drug and days-off-drug showed high p values (p =0.285 and 0.109), respectively. This indicated that TIR values days-on-drug and days-off-drug were normally distributed. Although, the distribution of TAR and TBR values days-on-drug and days-off-drug, were not normal as they had small p values (p< 0.05). Hence, further analysis of the paired set of data was done using the Wilcoxon signed-rank test. It revealed no difference in TIR, TAR, and TBR between the two groups (days-on-drug and days-off-drug). Conclusion Throughout the period of observation, the glycemic metrics (TIR, TAR, and TBR) remained steady with a 14 mg alternate-day oral semaglutide regimen.